High Fidelity Simulation-based Learning Approach in Maternal and Infant Care

NCT06722248 | Recruiting

• 1 other identifier: HFSBLBF1224
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

Study type: clinical trial - randomized control trial Primary purpose: to explore the effectiveness of high-fidelity simulation (HFS) interventions, specifically scenario-based training with pre-briefing and de-briefing on (1) knowledge and self-efficacy (2) problem solving abilities, (3) the learning experience among nursing students in baby care and breastfeeding, as compared to traditional training. Primary outcome: breastfeeding self-efficacy scores and knowledge in the intervention compared to the control group Secondary outcome: Simulation Design Scale and Education Practices Questionnaire

Conditions

High Fidelity Simulation Training

Keywords

"simulation training"; "high fidelity"; "infant care"; "breastfeeding"; "nursing student"

Outcome Measures

Primary Outcomes (2)

• Self efficacy on basic breastfeeding knowledge and skills with a self-rated breastfeeding ability tool

  37-items modified version was designed to estimate self-efficacy in performing tasks of different complexity, relating to breastfeeding support 1. \- Very simple for me to do 2. \- Easy for me to do 3. \- Difficult for me to do 4. \- Very hard for me to do For each question: minimum value = 1 and maximum value = 4 The higher scores mean a worst outcome (lower self efficacy).

  5min

• Level of knowledge and skill in caring for newborn baby and breastfeeding

  20 items 1. True 2. May be true 3. I dont know 4 = May be false 5 = False (for correct answer: 5 marks per questions, max total: 100) (for wrong answer: -5 marks per questions, min total: -100) (for may be: 2 to -2 marks; for i dont know: 0 marks) For each question: minimum value = -5 and maximum value = 5 The higher scores mean a better outcome (better knowledge).

  4min

Secondary Outcomes (2)

• Simulation Design Scale (SDS)

  3min

• Education Practices Questionnaire (EPS)

  3min

Other Outcomes (1)

• Demographic Questionnaire

  2min

Study Arms (2)

Intervention group with HFS baby

EXPERIMENTAL

For intervention group, the high fidelity simulation session will be arranged earlier. .

Behavioral: high fidelity simulation-based training; Behavioral: conventional training

Control group with conventional

OTHER

For control group, they will undergo convention training. An identical simulation session will be provided for the control group after completion of the study

Behavioral: conventional training

Interventions

high fidelity simulation-based training BEHAVIORAL

The intervention is a two-hour high-fidelity simulation training session focusing on newborn assessment, care practices, skin-to-skin contact, and breastfeeding. It uses SimBaby mannequins and breastfeeding models to mimic the hospital environment. Scenarios are tailored to nursing students' learning levels and reviewed by experienced midwives. The training includes: Prebriefing: Introduction of learning objectives, scenario background, simulation familiarization, confidentiality discussions, and ground rules. Intervention: Scenario-based training on baby care and breastfeeding. Debriefing: Plus-delta debriefing model reviewed by simulation educators. The training will be conducted in the nursing simulation laboratory.

Intervention group with HFS baby

conventional training BEHAVIORAL

Conventional training includes lecture, tutorial and basic lab with low-fidelity mannequins.

Control group with conventional; Intervention group with HFS baby

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• undergraduate nursing students
• newly enrolled obstetric course
• can provide consent for simulation confidentiality
• do not have previous clinical experience or training in obstetrical units

You may not qualify if:

• Nil

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Hong Kong Metropolitan University

Hong Kong, Hksar, Hong Kong

RECRUITING

Related Publications (35)

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Related Links

• National League for Nursing. Simulation Design Scale (Student Version) (2005)
• National League for Nursing. Educational Practices Questionnaire (Student Version) (2005)
• Create a blocked randomisation list

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Wai Ming CHUNG

  hku

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wai Ming CHUNG

CONTACT

69796719; h0394197@connect.hku.hk

Yuet Wan Lok, Dr

CONTACT

31976690; krislok@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The allocation of students into the block lists (intervention or control group) on the computer will be kept confidential and sealed in envelopes.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Block randomization with random block size 4, 6 will be used to allocate participants into intervention or control group using a online block randomization list generator

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 11, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)